NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Although scientific and technological advances have improved the health of the U.S. population overall, racial/ethnic minority populations, socioeconomically disadvantaged populations and rural populations continue to experience a disproportionate share of many chronic diseases and adverse health conditions. As the Nation’s steward of biomedical and behavioral research, NIH has devoted considerable resources to characterize the root causes of health disparities, uncovering complex webs of interconnected factors (e.g., biological, behavioral, social and environmental factors) acting at multiple levels across the life course. As an important next step, research is needed that capitalizes on this knowledge to develop interventions that reduce and eventually eliminate health disparities.

Tackling the complex drivers of health disparities requires a transdisciplinary framework that cuts across scientific and organizational silos to integrate multiple disciplines biology, behavioral and social sciences, epidemiology, data science, public health, health care delivery, economics, environmental science, public policy, etc. It also requires strong collaborations between researchers, community organizations, health service providers, public health agencies, policymakers and other stakeholders to ensure that relevant, contextually appropriate research is conducted and, more importantly, that findings can be translated into sustainable community and system-level changes that promote health equity.

To pursue these objectives, NIMHD Transdisciplinary Collaborative Centers (TCCs) for health disparities research comprise regional coalitions of research institutions and consortium partners focused on priority research areas in minority health and health disparities. The TCC program's overarching goal is to develop and disseminate effective interventions that can be implemented in real-world settings.

Chronic diseases and conditions are among the most common, costly, and preventable of all health problems. Seven of the top 10 causes of death in 2010 were chronic diseases. By investing in prevention and early diagnosis and treatment of the most common chronic diseases, the U.S. could decrease treatment costs by $218 billion per year and reduce the economic impact of disease by $1.1 trillion annually. Reducing disparities in chronic diseases should start with health disparity populations at high risk for chronic diseases such as cardiovascular diseases, diabetes, cancer, chronic pulmonary disease, arthritis etc. For example, many health risks are associated with obesity. However, the prevalence of obesity among non-Hispanic black and Hispanic adults is significantly higher than among non-Hispanic white adults. Cigarette smoking is the leading cause of preventable death in the United States. Yet, more adults who live below the poverty level are current cigarette smokers compared to those who live at or above the poverty level. Also, hypertension, a precursor to cardiovascular disease, is more prevalent and not as well controlled in non-Hispanic blacks, versus non-Hispanic whites. Non-Hispanic blacks have a much higher prevalence of uncontrolled blood pressure when compared with non-Hispanic whites. Women from poor, low-income, and middle-income households are less likely to receive a mammogram compared with women from high-income households.

Chronic diseases/conditions are defined broadly as conditions that last one year or more and require ongoing medical attention or limit activities of daily living or both. For the purposes of this FOA, chronic diseases/conditions that disproportionately affect health disparity populations include but are not limited to diabetes, cancer, cardiovascular diseases, kidney disease, HIV/AIDS, asthma, depression and other mental illnesses, substance abuse and addiction disorders.

Current science advances in developmental biology, life-course science and environmental epigenetics expand our understanding of the possible etiologies and mechanisms of many chronic diseases and conditions. The advances also build a persuasive case for reframing public health research efforts to emphasize health promotion and chronic disease prevention.

This initiative encourages investigators using a transdisciplinary, collaborative and systems approach to address disparities in chronic disease prevention. Priorities will be given to primary and secondary prevention activities that aim to prevent disease from occurring or aim to find and treat disease early. No treatment costs will be covered. Multilevel approaches are encouraged in order to better understand and appropriately intervene to eliminate health disparities. Multilevel interventions are interventions with multiple components designed to affect factors in two or more levels of the local ecology that contribute to wellness and illness, with the goal to effect changes within and between different levels. Dynamic interventions involving individual, family/team/group, community, state, or national levels may account for multidimensional influences on individual risk factors and population level macro-social factors. For example, evidence suggests that population-level behavior changes can best be achieved by changing physical and social environments for four key risk factors: tobacco use, unhealthy diet, lack of physical activity, and harmful use of alcohol. Increasingly, there is recognition that single-level interventions are not adequate to reduce health inequalities. Multilevel interventions that take into account complex interactions at multiple ecological levels can better address social determinants of health.

This FOA encourages working extensively with community partners to implement community-based multilevel interventions. For the purposes of this FOA, community is defined as a group of people with diverse characteristics who are linked by social ties, shared common perspectives, and engage in joint action in geographical locations. Each TCC will identify a community with existing evidence of a high prevalence or incidence of chronic diseases or conditions and lack of prevention and health promotion interventions or resources. In the project’s first year, each TCC is expected to carry out a comprehensive needs assessment in that community (including social stratification, community ecological context, cultural factors, environmental factors, health-related policies, etc.), identify barriers to access and utilization of health promotion or preventive care services, build extensive partnership within the community, and acquire baseline data on multiple chronic diseases including clinical data, biomarkers, or other measureable outcomes as necessary. Multimodal methods should be used to triangulate findings and identify the underlying mechanisms of disparities. Based on that information and collaboration with local community partners, in years 2-5 each TCC will initiate and implement multilevel interventions at individual, family/team/group, community, or higher levels (at least three or more levels) to improve chronic disease prevention and promote health equity.

Given that TCCs for health disparities research are focused on regional approaches and collective impact, priority will be given to multilevel interventions that target 500 or more participants within the selected community(ies), and to projects targeting communities without previous government-sponsored community-wide interventions.

Each TCC must consist of multidisciplinary teams of personnel from community organizations and academic institutions, health service providers and systems, and state and local public health agencies to address disparities through a multilevel approach that utilizes community, academic, and governmental resources. Each TCC must include the following components: Administrative Core, Consortium Core, Methodology Core, Intervention Projects, and Dissemination Core.

• The Administrative Core will oversee activities providing overall project evaluation; ensuring that component plans are implemented according to proposed timelines; submitting annual progress reports; monitoring progress on intervention projects, and ensuring that TCC-supported research is carried out in compliance with applicable federal regulations and policies.
• The Consortium Core will serve as a focal point for organizing and nurturing productive working relationships with consortium partners. Consortium Core leadership is expected to include members of all consortium partner organizations including NIMHD scientific staff. Research shows that diverse teams working together to capitalize on innovative ideas and distinct perspectives outperform homogenous teams. Moreover, involving community stakeholders in needs assessment, project planning and design, implementation, and dissemination of results enhances their participation in research and facilitates development of workable multilevel interventions.
• The Methodology Core will formulate appropriate theoretical framework, study design, data analysis plan, and assessment of community-based multilevel interventions. Investigators must carefully determine the unit of intervention and the unit of analysis according to their research questions. The systematic appraisal of costs and benefits of community-based multilevel intervention is needed.
• Intervention Projects will promote prevention research and related activities aimed at initiating and implementing multilevel interventions in community settings, working in close collaboration with community partners, health service providers, public health agencies, policymakers and other consortium partners as appropriate. Each TCC is required to have at least two projects with different interventions. Multiple chronic disease/conditions are encouraged.
• The Dissemination Core will identify, develop effective methods, systems, infrastructures, and strategies to disseminate research findings and to overcome barriers to the adoption, adaptation, integration of evidence-based multilevel interventions.

NOTE: TCC awards will not support cores that duplicate institutional resources or cores supported by other federal funding if those resources are already available for use by TCC participants.

To promote optimal use of TCC resources, TCC investigators are strongly encouraged to collaborate with other federally-funded investigators who have expertise and/or interest in multilevel chronic disease prevention and health disparities or other resources that can be leveraged to help achieve TCC objectives.

Although delineation of the region and populations(s) under study is determined by the applicant, applications must specify in which of the 10 established HHS regions the proposed work will occur (http://www.hhs.gov/about/regions/). Applicant-defined regions may fall within a single HHS region or across multiple regions.

REGION I: CT, ME, MA, NH, RI, VT
REGION II: NJ, NY, PR, VI
REGION III: DE, D.C., MD, PA, VA, WV
REGION IV: KY, MS NC, TN, AL, FL, GA, SC
REGION V: IL, IN, MI, MN, OH, WI
REGION VI: AR, LA, NM, OK, TX
REGION VII: IA, KS, MO, NE
REGION VIII: CO, MT, ND, SD, UT, WY
REGION IX: AZ, CA, HI, NV, and the six U.S. Associated Pacific jurisdictions
REGION X: AK, ID, OR, WA

To ensure that all TCCs, including those established through this FOA, contribute optimally and effectively to national minority health and health disparities research efforts, the overall direction and scope of activities supported by this initiative will be coordinated and monitored by a TCC Program Coordinating Committee consisting of TCC PDs/PIs and NIMHD program staff. The TCC Program Coordinating Committee will meet at least annually to assess progress toward program goals and promote information exchange across regions.

In addition, TCCs established through this initiative are expected to work together to address disparities in chronic disease prevention through a Multilevel Chronic Disease Prevention (MCDP) Coordinating Committee comprising the PD(s)/PI(s) of each TCC and NIH program staff. This committee will identify issues that have broad applicability across participating TCCs, and will establish the following sub-committees, each of which will include at least one NIH project scientist:

• Executive Committee, consisting of the chair of the MCDP Coordinating Committee, the TCC PDs/PIs, the NIH Program Officer(s), to meet quarterly via teleconference.
• Research Methodology Committee, consisting of key personnel from each TCC Methodology Core and NIH program staff and responsible for development of consistent definitions, theoretical frameworks, key approaches, and analytic methods.
• Publications Committee responsible for developing a publications policy approved by the Coordinating Committee at the beginning of the project period and reviewing all abstracts, presentations and manuscript submissions by MCDP TCC investigators.

The NIMHD will conduct a Technical Assistance webinar for prospective applicants in August 2015 at a date and time to be determined. Information about the webinar will be posted on the NIMHD website at www.nimhd.nih.gov.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Only one application per organization (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Maryline Laude-Sharp, PhD
Telephone: 301-451-9536
Fax: 301-480-4049
Email: mlaudesharp@mail.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	12
Core (use for Consortium Core, Methodology Core, and Dissemination Core)	6 (per core)
Project (use for Intervention Project)	12 (per project)

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Consortium Core: required
• Methodology Core: required
• Dissemination Core: required
• Intervention Project: required, minimum of two, maximum of three

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Describe the overall composition, objectives, specific aims, and expected outcomes of the proposed TCC. Identify the health disparity population(s) to be included in the proposed projects and describe the chronic diseases/conditions of focus. Delineate the geographic region to be covered, including the HHS region(s) where the proposed work will occur.

Research Strategy: Identify and delineate the roles of consortium partners. Provide the scientific rationale for selecting the partners and the population(s) to be included. Describe how the proposed TCC structure and activities will facilitate productive collaborations, bringing together people with expertise in multilevel chronic disease prevention.

Describe steps taken prior to or during the development of the application to gain substantive community input on (1) identification of research topics of importance to the study population(s), and (2) identification of relevant contextual factors (e.g., social stratification, community ecological context, cultural factors, environmental factors, health-related policies, etc.) to be considered alongside individual risk factors.

Explain how the various TCC activities taken together as a whole will significantly contribute to the integration of chronic disease prevention interventions taking into account the dynamic interplay between biological, behavioral, social and environmental health risk and protective factors experienced across the life course.

Explain how the proposed TCC activities will enhance inclusion of health disparity populations in chronic disease prevention and health promotion research.

Provide an overview of the proposed collaborative intervention projects and describe plans to promote synergy among them. Describe the scientific rationale and the process used to select the proposed intervention projects, as well as plans and procedures to monitor and assess progress on those projects. It is expected that under-performing projects will be discontinued and replaced by new projects with greater potential as the program evolves and matures.

Identify collaborating NIMHD-supported investigators in the region (if any) who have expertise in multilevel chronic disease prevention or other relevant resources that could be leveraged to help achieve TCC goals and objectives and avoid unnecessary duplication. Describe plans for leveraging any existing core facilities or other shared research resources that are available to support the proposed activities.

Describe the applicant organization's commitment and capabilities for regional coordination and collaboration, particularly with community-based organizations, federal, state and local agencies and private sector partners. Applicant organizations that currently hold federally-funded center awards should describe center expertise and resources available to support the proposed TCC activities, as well as how TCC activities are distinct from those of the existing center(s).

Letters of Support: Provide a letter or memorandum of agreement/understanding (MOA/U) for each proposed consortium partner organization, signed by an authorized official of that organization, describing its expectations for the partnership and its roles and responsibilities on the project.

The application should also include a detailed statement from the applicant organization's leadership describing its commitment to the establishment and maintenance of the proposed center. Support may include but is not limited to provision of professional release time, support staff, facilities, and other resources that will contribute to the proposed TCC activities.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Describe aims to ensure effective management, coordination and support of the TCC's chronic disease prevention research program and related consortium activities.

Research Strategy: Describe the TCC’s organizational and governance structure and explain the roles and responsibilities of Administrative Core personnel. Describe the processes to be used to allocate and prioritize fiscal and other resources, as well as procedures for ensuring timely and effective communication between TCC consortium participants. Include a management plan that describes the composition and roles of the Steering Committee, as well as any community advisory boards or other committees proposed to help manage TCC activities. Do not name potential members of the Steering Committee in the application.

Describe how the Administrative Core will manage, coordinate and supervise the entire range of proposed TCC activities, monitor progress on intervention projects, and ensure that component plans are implemented according to proposed timelines.

Include an evaluation plan to monitor progress on proposed TCC activities. The evaluation plan is intended to facilitate ongoing TCC project management to ensure successful completion of the stated aims. Describe how the evaluation will be conducted, logic models for the TCC as a whole and for each proposed core, principal measures and metrics to be used to assess achievement of short- and long-term goals, and potential sources of data. The plan should address administrative functioning (process) as well as scientific accomplishments (outcomes) in the following key areas: translational activities; scope and impact of research; innovation; collaboration and communication; integration and synergy; and funds management. Describe key milestones and expected outcomes for each area as appropriate.

NOTE: Under the cooperative agreement mechanism, NIMHD staff will work with TCC award recipients to develop complementary evaluation methods and measures addressing the scientific impact of the TCC program at regional and national levels.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Not Applicable

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Consortium Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Consortium Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Consortium Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Consortium Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Consortium Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Consortium Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Consortium Core)

Specific Aims: Describe the aims and objectives that will be pursued to establish the Core as a regional focal point for organizing and nurturing productive working relationships with a broad cross-section of community organizations, health disparity populations, health service providers, public health agencies and other stakeholders with an interest in eliminating health disparities. Describe aims to ensure effective management, coordination and support of the TCC's multilevel chronic disease prevention research program and related consortium activities.

Research Strategy: Explain the scientific rationale for including the consortium partners in research involving the proposed study population(s). Summarize the strengths of the proposed consortium, including relevant expertise, relationships with the study population(s), and experience participating in productive regional collaborations and partnerships.

Describe specific opportunities to establish or strengthen associations with federal agencies, state and local health departments and other relevant agencies with expertise and/or interest in the proposed research, implementation and dissemination activities. Describe strategies and procedures for assessing the effectiveness of partnerships on an ongoing basis and resolving disputes or misunderstandings between partner organizations.

Letters of Support: Letters or memoranda of agreement/understanding signed by authorized representatives of consortium partner organizations are to be included in the application's Overall Component and should not be duplicated in the Consortium Core component.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Consortium Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Consortium Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Methodology Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Methodology Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Methodology Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the

Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Methodology Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Methodology Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Methodology Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Methodology Core)

Specific Aims: Describe the aims and objectives that will be responsible for development of consistent definitions, theoretical framework, key approaches, and analytic methods for multilevel chronic disease prevention.

Research Strategy: Describe the roles and responsibilities of key members involved in this core, as well as any additional collaboration with regional partners with methodology expertise. Core leadership should include individuals that are likely to be critical to the research methods and study design. Expertise on economic evaluation is needed.

Describe a comprehensive needs assessment in the community (including social stratification, community ecological context, cultural factors, environmental factors, health-related policies, etc.). Describe how to identify barriers to access and utilization of health promotion or preventive care services and acquire baseline data on multiple chronic diseases (including clinical data, biomarkers, or other measureable outcomes as necessary). Multimodal methods should be used to triangulate findings and identify the underlying mechanisms of disparities.

Describe the theoretical or conceptual model supporting the multilevel chronic disease prevention, as well as the levels proposed in the intervention and the analytic plan to address its impact on individual-level and contextual factors, the interaction between them and how they influence each other dynamically. Describe the capabilities of data collection, integration and analysis. Describe the scalability and sustainability of the proposed study design to reduce disparities in chronic disease prevention.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Methodology Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Methodology Core)

Not Applicable

When preparing your application in ASSIST, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Intervention Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Intervention Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Intervention Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components

Project /Performance Site Location(s) (Intervention Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Intervention Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Intervention Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Intervention Project)

Specific Aims: State concisely the overall goals of the proposed intervention project. Identify the health disparity population(s) to be included and the chronic disease(s) or condition(s) under study. List succinctly the specific objectives, e.g., to test a stated hypothesis, create a novel design, solve a specific problem relating to health disparities, challenge an existing paradigm, address a critical barrier to progress in the field of chronic disease prevention and health promotion as it relates to health disparities, or develop new technology.

Research Strategy: For research involving human subjects, describe steps taken prior to and/or during the development of the application to obtain substantive community input into (1) identification of research topics of importance to the proposed study population(s), and (2) identification of relevant contextual factors (e.g., social stratification, community ecological context, cultural factors, environmental factors, health-related policies, etc.) that mediate the effects of interventions targeting health disparities populations.

Explain how the proposed collaborations will serve to advance scientific knowledge of the interplay between biological, behavioral, social and environmental risk and protective factors experienced across the life course.

Describe the multilevel approach used in the project. Describe in detail all levels proposed to receive interventions and how the partners are going to support such interventions to reduce health disparities. Describe what type of prevention, primary or secondary, are adopted. Also describe what chronic disease/condition is being targeted and what potential clinical and other outcome is anticipated. Describe the timeline of the proposed multilevel intervention and what resources are already available to develop and conduct such interventions.

Explain how the project will complement and synergize with other intervention projects included in the application, and how its successful completion will advance the TCC's overall aims and objectives. Also address plans for leveraging TCC infrastructure and resources to ensure successful completion of the project's stated aims.

Applications with foreign components that involve data collection in foreign sites must state how the proposed activities will help improve minority health or reduce health disparities in the United States. Applications that do not include this information are non-responsive to the FOA

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Intervention Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Intervention Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Dissemination Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Dissemination Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Dissemination Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Dissemination Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Dissemination Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Dissemination Core)

Specific Aims: Describe the aims and objectives that will be pursued to support regional dissemination of multilevel chronic disease prevention, including new interventions developed through collaborative intervention projects, in collaboration with relevant communities, service providers, other partner organizations and policy makers.

Research Strategy: Describe the roles and responsibilities of consortium partners involved in this core, as well as any additional collaboration with health service providers, public health agencies, policymakers and other relevant stakeholders. Core leadership should include individuals from organizations that are likely to be critical to the dissemination process and able to use knowledge generated through research to make informed decisions about policies, programs and/or practices.

Describe strategies to use research findings to inform policy and to promote diffusion, adoption and sustainability of effective multilevel interventions in relevant communities within the proposed region. Address ethical considerations for (1) development and/or utilization of variables and measures in study populations, and (2) communicating research results to the scientific community and the lay public. Describe plans to ensure protection of study participants and communities from unintended harms, including risks associated with stigma.

Describe strategies to keep various stakeholders informed, on an ongoing basis, of needs and capacity assessments, as well as results from intervention projects. Describe steps to assess the effectiveness of community- or system-level dissemination of interventions and/or health education efforts.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Dissemination Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Dissemination Core)

Not Applicable

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIMHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the center proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

How likely is the project to yield new insights into the community-based multilevel intervention to address reduction of disparities in chronic disease prevention in one or more health disparity populations?

How and to what extent are the proposed activities likely to enhance inclusion of health disparities populations in chronic disease prevention research?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partner organizations raise confidence that each partner organization is actively engaged and committed to achieving the project's stated aims?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the proposed team include people with demonstrated expertise in prevention research, multilevel intervention methodology, population health disparities, big data and novel technology, and the science of translation, implementation and dissemination? Have the PD(s)/PI(s) demonstrated a history of productive working relationships as scientific collaborators, both in academic settings and in consortia that include community-based organizations and other stakeholders? Do the partnerships match with the resources needed for the specific intervention project?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partner organizations describe adequate qualifications, roles and responsibilities of senior/key personnel and other significant contributors at those organizations and raise confidence that their involvement will facilitate achievement of the stated aims?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the application propose an innovative conceptual framework, novel strategies or approaches for integrating individual and contextual level data such that chronic disease prevention interventions are appropriately informed by multilevel factors that influence health outcomes?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Taken together as a whole, are the proposed TCC activities likely to promote community-based multilevel interventions that take into account the dynamic interplay between biological, behavioral, social and environmental health risk and protective factors experienced across the life course? Are the research designs creative to capture the complexities of different factors?

Is it likely that the proposed TCC activities are sustainable, scalable, and affordable? Is what is proposed likely to reduce, eliminate or prevent a disparity, based on the supporting theoretical or conceptual model?

Is there convincing evidence of substantive community input into the selection of proposed research topics and the identification of relevant community and/or population-level contextual factors to be examined alongside individual risk factors?

Do letters or memoranda of agreement/understanding (MOA/U) from proposed consortium partner organizations describe adequate roles and responsibilities of each organization in carrying out the proposed TCC activities and raise confidence that their involvement will facilitate achievement of the stated aims?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the applicant organization describe its commitment to the establishment and maintenance of the proposed center in terms that raise confidence in the prospects for success?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score for the Administrative Core, but will not give separate scores for these items.

Are strategies to ensure effective management, coordination and support of the TCC's multilevel chronic disease prevention program and related consortium activities well described and likely to succeed? Do the proposed approaches for coordinating and supervising TCC activities raise confidence that each component's aims will be achieved within the project period?

Is the TCC organizational and governance structure adequately described and appropriate for supporting the stated aims? Does the management plan adequately describe the composition and roles of the TCC Steering Committee and any other committees proposed to help manage TCC activities? Are appropriate resources and processes in place to ensure that TCC-supported research will be carried out in compliance with applicable federal regulations and policies?

Does the applicant include an evaluation plan with a logic model that incorporates appropriate performance targets, objectives, and intervention outcomes (including economic evaluation)? Is the proposed evaluation plan well-conceived and described in sufficient detail to judge its utility for ongoing project management? Is its execution likely to facilitate successful completion of the TCC's stated aims?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score for the Consortium Core, but will not give separate scores for these items.

Are the aims and objectives of the Core well described as a regional focal point for organizing and nurturing productive working relationships with community organizations, minority and health disparity populations, health care provider organizations, for-profit or non-profit organizations and other stakeholders with an interest in using multilevel chronic disease prevention approaches to improve health equity? Are the proposed strategies to keep consortium partners and other stakeholders informed on an ongoing basis of TCC activities adequately described and likely to be effective? Does the applicant involve more than one community-based organization/American Indian Tribal Government, either as the applicant or partnering organization?

Are consortium partner organizations and their respective roles and contributions clearly articulated? Is the scientific rationale for including the consortium partners in research involving the proposed study population(s) clear and consistent with the overall objectives of the proposed TCC? Do consortium participants have relevant expertise, working relationships with the study population(s), and experience participating in productive collaborations and partnerships? Does the Consortium Core leadership include qualified representatives from consortium partner organizations?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score for the Methodology Core, but will not give separate scores for these items.

Is there existing evidence of a high prevalence or incidence of chronic diseases or conditions and lack of prevention and health promotion interventions or resources in the community identified? Is there documentation that these communities have a higher prevalence or worse outcomes than other communities? Does the community include significant representation from one or more US health disparity populations (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations and rural populations)? Do the proposed interventions involve 500 or more participants within the community?

Are the theoretical or conceptual models provided supporting the multilevel chronic disease prevention? Are the levels proposed in the intervention adequate and reasonable? Can the analytic plan address the impact on different levels and the interaction between them and how they influence each other dynamically? Can the proposed study design improve the scalability and sustainability of community-based multilevel intervention?

Does the Core encourage and sustain active participation of investigators and partners to explore new methodologies or approaches, generate baseline data to support the study design and program evaluation, and implement promising multilevel interventions in community settings?

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the application describe steps taken prior to and/or during the development of the application to obtain substantive community input into (1) identification of research topics of importance to the proposed study population(s), and (2) identification of relevant contextual factors (e.g., social stratification, community ecological context, cultural factors, environmental factors, health-related policies, etc.) that mediate the effects of interventions targeting health disparities populations?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the application explain how the proposed collaborations will serve to advance scientific knowledge of the interplay between biological, behavioral, social and environmental risk and protective factors experienced across the life course?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Does the application describe the multilevel approach used in the project, including details on all levels proposed to receive interventions and how the partners are going to support such interventions to reduce health disparities? What types of prevention, primary or secondary, are adopted? What chronic disease/condition is being targeted and what potential clinical and other outcomes are anticipated? Is the timeline of the proposed multilevel intervention included, and does the application describe resources already available to develop and conduct such interventions?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score for the Intervention Project, but will not give separate scores for these items.

Complementarity of Intervention Projects

Does the application explain how the project will complement and synergize with other intervention projects included in the application, and how its successful completion will advance the TCC's overall aims and objectives?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score for the Dissemination Core, but will not give separate scores for these items.

Are the proposed activities likely to promote or enhance dissemination of multilevel chronic disease prevention in collaboration with relevant communities, service providers, other partner organizations and policy makers? Are steps to assess the effectiveness of dissemination efforts adequately described and appropriate?

Is there an appropriate plan to dissemination project findings to the community at large (rather than just community partners)? Does the application adequately address ethical considerations for (1) development and/or utilization of variables and measures in study populations, and (2) communicating research results to the scientific community and the lay public? Are plans to ensure protection of participating communities or groups from unintended harms, including risks associated with stigma, adequately addressed?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIMHD in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Minority Health and Health Disparities. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic distribution of award recipients.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the award recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Coordinating project activities technically, scientifically and administratively at the recipient institution and coordinating project activities at other sites that may be supported by the award.
• Defining objectives and approaches; collecting and analyzing data; and publishing results, interpretations, and conclusions of studies conducted under the terms and conditions of the award.
• Ensuring that appropriate Institutional Review Board approvals and certifications for research involving human subjects for all participating sites, collaborators or partners are obtained.
• Selecting external members for and participating in the TCC Consortium Steering Committee.
• Organizing an annual face-to-face meeting of the TCC Consortium Steering Committee.
• Consulting with NIMHD to ensure compliance with relevant grant policies and regulations.
• Participating in the TCC Program Coordinating Committee meetings and other PD/PI meetings convened by NIMHD.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIMHD will assign a Program Official (see below) and Project Scientist(s) to the TCC award. The Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. Project Scientists(s) will:

• Review and comment on critical stages in the program implementation;
• Assist in the interaction between the recipient and investigators at other institutions to promote collaborations;
• Assist in coordinating access to other resources available through statewide, regional, or national specialized cores or resources;
• Retain the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
• Retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget;
• Convene meetings/workshops to address emerging areas of high priority.

Additionally, the NIMHD program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official will:

• Assist with the NIMHD’s monitoring of compliance of award-supported activities;
• Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
• Help ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer-reviewed funding mechanisms;
• Provide assistance in reviewing and commenting on all major transitional changes of TCC activities prior to implementation to ensure consistency with the goals of this FOA;
• Link the approaches developed from the TCC to other NIMHD-supported activities to ensure that information is shared and utilized on the widest basis possible;
• Monitor institutional commitments and resources to help ensure that the TCC receives the maximum chance of stabilization and success;
• Assist with the NIMHD’s monitoring of financial oversight of the Program.

Areas of Joint Responsibility include:

• Establishing a TCC Steering Committee consisting of: 1) the PD(s)/PI(s); 2) two or more members representing consortium partner organizations, with at least one representative from a non-research institution, 3) two external members selected by the PD(s)/PI(s); 4) the NIMHD Program Official; and 5) the NIH Project Scientist(s). Each committee member will have one vote except for the NIH staff members, who will share one vote. The TCC Steering Committee will convene by telephone as needed and will meet in person at least once a year.
• Identifying and facilitating partnerships with other NIMHD award recipients in the respective regions with expertise and/or interest in multilevel chronic disease prevention and health disparities or other relevant resources and expertise that could be leveraged to facilitate achievement of the TCC Program goals and objectives.
• Organizing and participating in the TCC Program Coordinating Committee meetings at least annually to discuss matters of mutual interest and promote information exchange across regions.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual award recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Xinzhi Zhang, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-6136
Email: Xinzhi.Zhang@nih.gov

Maryline Laude-Sharp, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-9536
Email: mlaudesharp@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.